A Digital Twin for Exoskeleton Pilot

March 17, 2025 updated by: National Taiwan University Hospital
Although exoskeletons have been studied for many years, actual products have been sold on the market. However, there are still many limitations in the practical application of exoskeletons, and the control logic is also limited to the level of motor torque compensation, and lacks the consideration of overall motion stability (such as whether the wearer (driving, pilot) will fall). The purpose of this project is to establish a digital twin of this driving, which will perform the driving action in parallel, and calculate in parallel in the virtual environment the torque required to provide each joint torque to maintain stable walking without falling, and this torque can be used as a monitoring basis for the auxiliary torque of each axis for the exoskeleton. When the exoskeleton's movements are out of range of a stable gait, the controller can warn and attenuate the output of auxiliary forces, and on the other hand, it has the opportunity to analyze whether the intention of driving is to switch the movement mode - such as stopping, or sitting, squatting, etc.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This project is expected to use different machine learning models to make accurate predictions of human intent when healthy people drive different actions or action transitions of common human actions. Drivers will wear sensors such as inertial measurement unit (IMU) and electromyography (EMG) in the lower limbs to measure body signals of participants during actions in a non-invasive way, and let the system calculate the joint angle, angular velocity and angular acceleration of each joint of the driving lower limb related human signals.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taipei,Taiwan, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Can stand independently and walk for more than 5 minutes.
  2. According to age, it can be divided into: elderly groups (aged between 50~80 years old); Young people (aged 18~50 years).

Exclusion Criteria:

  1. Have current or previous neurological diseases of the lower extremities, such as: acute neuritis, stroke, Parkinson's disease.
  2. Have current or previous orthopedic diseases of the lower extremities, such as: knee replacement, rheumatoid arthritis, or sports injuries and other symptoms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A Digital Twin for Exoskeleton Pilot
This project is expected to use different machine learning models to make accurate predictions of human intent when healthy people drive different actions or action transitions of common human actions. Drivers will wear sensors such as inertial measurement unit (IMU) and electromyography (EMG) in the lower limbs to measure body signals of participants during actions in a non-invasive way, and let the system calculate the joint angle, angular velocity and angular acceleration of each joint of the driving lower limb related human signals.
Other: A Digital Twin for Exoskeleton Pilot
The purpose of this project is to establish a digital twin of this driving, which will perform the driving action in parallel, and calculate in parallel in the virtual environment the torque required to provide each joint torque to maintain stable walking without falling, and this torque can be used as a monitoring basis for the auxiliary torque of each axis for the exoskeleton. When the exoskeleton's movements are out of range of a stable gait, the controller can warn and attenuate the output of auxiliary forces, and on the other hand, it has the opportunity to analyze whether the intention of driving is to switch the movement mode - such as stopping, or sitting, squatting, etc.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The angles of the subject's joints.
Time Frame: 3 years
The angles of the subject's joints (unit: degree) are performed by using IMU sensors when subjects do some action such as standing, walking or sitting.
3 years
The activities of muscles state of human movement.
Time Frame: 3 years
The activities of muscles state of human movement (unit: millivolt or %) are performed by using EMG sensors when subjects do some action such as standing, walking, sitting, squatting or step-up.
3 years
The comprehensive intention of the subjects.
Time Frame: 3 years
The comprehensive intention time of the human body (unit: second) is performed by using IMU sensors and EMG sensors when subjects do some action such as standing, walking, sitting, squatting or step-up.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Wei-Li Hsu, Ph.D, Study Principal Investigator National Taiwan Unversity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202209051RINB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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